• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 38MM ATTUNE IMPLANT : KNEE PATELLA

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 38MM ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-20-038
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 08/12/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint #:(b)(4) if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Clinical adverse event received for deep venous thrombosis. Event is not serious and is considered moderate. Event is definitely not related to device and probably related to procedure. Date of implantation: (b)(6) 2020. Date of event (onset): (b)(6) 2020. (left knee). Treatment: oral medication (unspecified).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameATTUNE MEDIAL DOME PAT 38MM
Type of DeviceATTUNE IMPLANT : KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11971140
MDR Text Key255371075
Report Number1818910-2021-12290
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1518-20-038
Device Catalogue Number151820038
Device Lot Number9421039
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/09/2021 Patient Sequence Number: 1
Treatment
ATTUNE CRS FB INSRT SZ 4 6MM; ATTUNE CRS FEMORAL LT SZ 4 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATUN TIB AUG UNIV SZ 3/4 5MM; ATUNE CRS FB TIB BASE SZ 4 CEM; ATUNE PRESSFIT STR STEM14X60MM; ATUNE PRESSFIT STR STEM20X60MM
-
-